Enhancing Trauma Resuscitation Through Arterial Line Integration: A Before-After Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index )
研究概览
简要总结
Accident-related deaths is the 7th leading cause of death in Taiwan, and most of them is due to trauma from falls and traffic accident. Among trauma patients, the common cause of death is from hemorrhagic shock. Thus, real-time and accurate blood pressure monitoring is important for trauma patients. Incorrect blood pressure monitoring can lead to adverse events like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid resuscitation, blood transfusion and operation). The current practice of blood pressure monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be incorrect and not timely. Patient's body type and peripheral perfusion can both influence the result of non-invasive blood pressure monitoring.
With continuous and correct blood pressure monitoring, the resuscitation team can give adequate and timely treatment. In some trauma centers, arterial line insertion in trauma patients is a daily practice, while the evidence is inadequate and the potential benefit in unknown.
The main purpose of this study is to investigate the application of arterial line insertion in trauma patients. The study design is a prospective before-after study to exam whether arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic shock and improve patient's outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glasgow Coma Scale (GCS) 13 or less
- •SBP < 90 mmHg
- •Respiratory rate < 10 or > 29 breaths/min
- •Fall from height > 6 meters
- •High-Risk Auto Crash: Partial or complete ejection, intrusion > 30 cm any site, Need for extrication for entrapped patient, Death in passenger compartment
- •Rider separated from transport vehicle with significant impact
- •Penetrating injuries to head, neck, torso, and proximal extremities
- •Skull deformity, suspected skull fracture
- •Chest wall instability, deformity, or suspected flail chest
- •Suspected pelvic fracture
- •Suspected fracture of two or more proximal long bones
- •Amputation proximal to wrist or ankle
- •Active bleeding requiring a tourniquet or wound packing with continuous pressure
- •Burns in conjunction with trauma
排除标准
- •Pregnancy
- •Patient or family who are unable to obtain informed consent
- •Known coagulopathy that is inappropriate for arterial line insertion
- •Known peripheral arterial occlusion disease that is inappropriate for arterial line insertion
- •traumatic cardiac arrest
结局指标
主要结局
composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index )
时间窗: during ER stay, up to 6 hours
including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)\>1
次要结局
- prolong ICU admission(up to 7 days)
- 30 days mortality rate(mortality within 30 days of trauma event)
- volume of fluid administration(during ER stay, up to 6 hours)
- Area under curve (AUC) difference under different time measuring frequency(1/3/5/10 minutes)
- units of red blood cell transfusion(during ER stay, up to 6 hours)
- arterial blood pressure trajectory(during ER stay, up to 6 hours)